Pphentermine pill/topiramate
Phentermine pill/topiramate Phentermine/topiramate Combination of Phentermine tablet urge for food reducer/stimulant of the amphetamine and phenethylamine class Topiramate anticonvulsant Identifiers ATC code None Therapeutic considerations Legal status experimental, but has been submitted to the FDA for authorization The mixture of the medication phentermine tablet and topiramate (commerce title Qnexa) is an investigational medicine for the remedy of obesity and associated circumstances reminiscent of sort 2 diabetes and has been found to decrease blood strain and cholesterol. 1 Qnexa is being developed by Vivus, a California pharmaceutical company. Phentermine pill is an appetite diminisher and stimulant of the amphetamine and phenethylamine category. Topiramate is an anticonvulsant that has weight reduction aspect effects. Qnexa is currently not permitted for use within the United States. It was rejected by regulators within the United States Meals and Drug Administration after a panel discovered that tests confirmed that it was associated with a lot of dangerous unwanted effects, including suicidal ideas, coronary heart palpitations, memory lapses and beginning defects. Scientific studies have proven weight reduction under treatment with Qnexa. The section three, 56-week EQUIP study showed that the typical heaviness lack of 14.7% (37 lbs) was achieved by overweight sufferers treated with Qnexa. The next doses of phentermine pill IR and topiramate CR where utilized in Phase 3 testing: * Full power system: 15 mg of phentermine pill IR (instant-launch) and ninety two mg of topiramate CR (controlled-launch) * Mid power method: 7.5 mg phentermine tablet IR and 46 mg topiramate CR * Low energy method: 3.75 mg phentermine IR and 23 mg topiramate CR The main unwanted side effects reported throughout testing phases had been dry mouth, a tingling within the fingers and toes, and constipation. On December 28, 2009 a brand new drug utility (NDA) was submitted to the FDA for sanction and on March 1, 2010, Vivus introduced that the company accepted the NDA. The target date for the FDA to complete its evaluation of the Qnexa NDA is October 28, 2010. The FDA's Endocrinologic and Metabolic Medication Advisory Committee is tentatively scheduled to overview Vivus' Qnexa on July 15, 2010. It is anticipated that this may present an indication on whether or not it's authorized or not. Qnexa can also be in phase 2 scientific improvement for the therapy of kind 2 diabetes and obstructive sleep apnea (OSA). A phase 2 safety and efficacy examine evaluating Qnexa in patients with OSA showed that patients who took Qnexa had a 69 p. C discount in sleep apnea events and lost extra weight than those that took placebo. Vivus at present has four U.S. Patents covering Qnexa. These patents are related to the product and strategies of using the drug in numerous therapeutic applications. Further research knowledge released indicates that Qnexa lowers blood pressure. Dr. Suzanne Oparil of the College of Alabama at Birmingham stated “The higher the dose, the extra weight reduction and the more blood stress went down” introduced on the American Society of Hypertension’s twenty fifth annual assembly in New York. In January 2011, the Food and Drug Administration expressed issues concerning the potential for Qnexa to trigger beginning defects and has requested Vivus to examine this chance earlier than the drug will be approved. Source: ShopPharmacyCounter